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Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift

Information source: Nguyen, Davis B., M.D.
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Intervention: Fibrin Sealant (Artiss) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Nguyen, Davis B., M.D.

Official(s) and/or principal investigator(s):
Davis B Nguyen, M.D., Principal Investigator, Affiliation: Davis B Nguyen, M.D.

Overall contact:
Davis B Nguyen, MD, Phone: 310 550 0288, Email: nguyendavisb@yahoo.com

Summary

The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.

Clinical Details

Official title: A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Comparison of ecchymosis and edema

Secondary outcome: Resolution of ecchymosis and edema, incidence of hematoma/seroma

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects planned for endoscopic browlift, subjects who read, understand and sign the

written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements Exclusion Criteria:

- Subjects who had previous browlift, subjects indicated for concurrent facial

surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.

Locations and Contacts

Davis B Nguyen, MD, Phone: 310 550 0288, Email: nguyendavisb@yahoo.com

Davis B Nguyen, M.D., Beverly Hills, California 90212, United States; Recruiting
Davis B Nguyen, M.D., Phone: 310-550-0288, Email: nguyendavisb@yahoo.com
Additional Information

Starting date: December 2010
Last updated: March 19, 2011

Page last updated: November 27, 2014

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